Kornimate/medical-research-clean huggingface dataset:
eras (early recovery after surgery) protocol after laparoscopic total gastrectomy and proximal gastrectomy

Conditions: Gastric Cancer

Summary: enhanced recovery after surgery (eras) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

there is strong evidence of the usefulness of the eras programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment. however, few studies exist about the implication of eras programs in the laparoscopic gastrectomy. the aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic total gastrectomy and proximal gastrectomy for gastric cancer, receiving either eras protocol or conventional postoperative cares.

Eligibility criteria:
inclusion criteria: * elective surgery * american society of anesthesiologists (asa) scores \< 3 * gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal gastrectomy * informed consent * no other treatment (radiation, chemotherapy or immunotherapy) on this gastric cancer or other type of cancer. * no systemic inflammatory disease exclusion criteria: * conversion to open

Keywords: gastric cancer eras (early recovery after surgery) laparoscopic total gastrectomy
effect of ketalar or dexmedetomidine on increased sensitivity to pain following treatment with remifentanil

Conditions: Cholecystectomy

Summary: analgesia is one of the pillars of anesthesia. one of the common opiates for pain relief, with a short half-life, is remifentanil. however, following remifentanil treatment an increased sensitivity to pain \[hyperalgesia\] appears. the aim of the study is to compare the effects between complementary treatments, like ketalar and dexmedetomidine, in preventing increased sensitivity to pain after remifentanil treatment

analgesia is one of the pillars of anesthesia. for many years, opiates were the basic ingredient in pain relief. the effectiveness of these substances in pain relief caused them to be overused which resulted in a global epidemic of addiction, morbidity and mortality due to the overuse of these drugs. some of the options for realizing a reduction in the use of opiates include the use of drugs with a more predictable pharmacological profile and a short half-life, such as remifentanil. this opiate is stronger than morphine and its half-life remains within a few minutes, without accumulation even after prolonged infusion. therefore, it seems that the use of remifentanil is ideal, especially for prolonged anesthesia. one of the severe complications following treatment with remifentanil is the appearance of increased sensitivity to pain \[hyperalgesia\] which results from a central sensitivity to pain and is expressed by stimulation of sensory receptors for pain in the nervous system (nociceptive sensitization). in order to alleviate the feeling of pain following the increased sensitivity to pain after treatment with opiates, as well as with remifentanil, complementary treatments, such as ketalar and dexmedetomidine, were offered. this study will compare the ability of ketalar or dexmedetomidine in alleviating increased sensitivity to pain after treatment with remifentanil in patients who are candidates for laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: • patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia exclusion criteria: * patients with sensitivity to the anesthetic * patients with chronic pain who are in regular treatment * urgent surgery * patients with ischemic heart disease * patients with known bradycardia * patients with a pacemaker * prolonged use of opiates * kidney/liver function problems
study evaluating chemotherapy in combination with inotuzumab ozogamicin in subjects with non-hodgkin's lymphoma

Conditions: Lymphoma, B-Cell

Summary: this is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with cd22-positive non-hodgkin's lymphoma. the trial will involve two arms. in one arm, subjects will receive chemotherapy regimen r-cvp (rituximab, cyclophosphamide, vincristine and prednisone). in the other arm, subjects will receive r-gdp (rituximab, gemcitabine, cisplatinum and dexamethasone). subjects in both arms will also receive inotuzumab ozogamicin.


Eligibility criteria:
inclusion criteria: * dose escalation cohorts: subjects with diagnosis of cd22-positive non-hodgkin's lymphoma (nhl) who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy. * expanded maximum tolerated dose (mtd) confirmation and preliminary efficacy cohorts: subjects with diagnosis of cd22-positive nhl who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy or newly diagnosed subjects who are not candidates for anthracycline-based therapy. * at least 1 measurable disease lesion that is \> 1 cm in the longest transverse diameter, with a product of the diameters \> 2.25 cm2 by ct or magnetic resonance imaging (mri). exclusion criteria: * candidate for potentially curative therapy such as stem cell transplantation. * prior allogeneic hematopoietic stem cell transplantation (hsct). * prior autologous transplantation, radioimmunotherapy, or other anti cd22 immunotherapy \<= 6 months before the first dose of investigational product. * more than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer regimens.

Keywords: non-hodgkin's lymphoma
multicentre observational study in posterior mechanical thrombectomy: conscious sedation vs general anesthesia

Conditions: Mechanical Thrombectomy; General Anesthesia; Conscious Sedation; Posterior Circulation

Summary: the association of conscious sedation vs. general anesthesia in ischemic stroke with posterior circulation occlusions undergoing endovascular therapy, is istill unknown. no prospective or clinical trials have studied this effect on posterior circulation strokes. the choice of anesthetic regimen is ussually depending on local stroke-team protocols or neurointerventional preference. morpheus stroke registry is a prospective multicentre observational study that investigates the association between anestheisa and functional outcome in patients with posterior circulation large vessel occlusion treated endovascularly.


Eligibility criteria:
inclusion criteria: * subject aged ≥ 18 years * evidence of posterior arterial occlussion (basilar artery, intracranial vertebral artery and posterior cerebral artery) * patients eligible for mechanical thrombectomy exclusion criteria: * patient's refusal to participate * arterial recanalization prior to endovascular thrombectomy attempt * patient unable to present or be available for follow-up
gel-200 versus placebo in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to determine if a single intra-articular injection of gel-200 is superior to a single injection of phosphate buffered saline (pbs) in subjects with symptomatic osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (grade 1-3 on kellgren - lawrence (k-l) score). exclusion criteria: * subjects with grade 4 on k-l score * subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis * serious systemic diseases * female subjects who are pregnant or lactating
responses to covid19 vaccination in patients with a treatment history of rituximab.

Conditions: COVID19 Vaccination; Rituximab; Immunosuppression

Summary: patients with treatment history of rituximab since 01.01.2019 and immunocompetent volunteers will be contacted to give a blood sample after their covid19 vaccination, and in a subset also before vaccination. immune responses of antibodies and sars-cov2-specific t-cells to the vaccination will be quantified and the rituximab effect on covid19 vaccine-induced immune responses is analyzed.


Eligibility criteria:
inclusion criteria: 1. patients who were treated with anti-cd20 treatment since 01.01.2010 2. patients who received a covid19 vaccination (completion of all required doses) until target date (initial target: 30.05.21, but can be delayed to 30.06.21, 30.07.21 or 30.08.21 in case of insufficient enrollment) 3. volunteers without a history of anti-cd20 treatment exposure 4. all: written informed consent. exclusion criteria: exclusion criteria for patients (any of the following) 1. patients aged 18 years and younger at time of study enrollment and/or 2. pregnant or lactating women at time of study enrollment and/or 3. patients who do not provide written informed consent and/or 4. patients who have previously had a covid19 infection (self-reported covid19 disease, positive pcr or serology) 5. patients who are in a dependency relationship with the study personnel (hierarchical, social) exclusion criteria for volunteers (any of the following) 1. volunteers aged 18 years and younger at time of study enrollment and/or 2. pregnant or lactating women at time of study enrollment and/or 3. volunteers who do not provide informed consent and/or 4. volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-cd20 treatment and/or 5. volunteers who have previously had a covid19 infection (self-reported covid19 disease, positive pcr or serology) 6. volunteers who did not complete their covid19 vaccination 7. volunteers who are in a dependency relationship with the study personnel (hierarchical, social)

Keywords: b-cells t-cells covid19 vaccine sars-cov2 rituximab
a study of the safety and effectiveness of a new treatment for allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: this study will evaluate the safety and efficacy of a new allergy medication

study withdrawn prior to determining study details

Eligibility criteria:
inclusion criteria: * be at least 6 years of age, of any race, or either gender. * have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months. * have a calculated best-corrected visual acuity of 0.6 logmar or better in each eye as measured using an etdrs chart. * positive bilateral cac reaction at visit 1 \& 2. exclusion criteria: * have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components. * any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters * manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit
umbilical vessel catheterization under ecg monitoring and guidance

Conditions: Pediatric ALL

Summary: umbilical venous catheters (uvc) are typically places with poor guidance and some radiological confirmation. misplacement of the catheter could lead to its placement in other unintended anatomical areas such as the liver or the spleen, which could be detrimental in critically-ill infants. our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram (ecg) tracings.


Eligibility criteria:
inclusion criteria: * neonate pediatric patient * 2 - 6kg * require or currently have uvc exclusion criteria: * participants who do not consent or have parental consent * patients who are clinically unstable

Keywords: neonates electrocardiogram umbilical vein catheterization
validation study of the malay version of 3d-cam

Conditions: Postoperative Delirium; Diagnosis, Psychiatric

Summary: validation of the malay version of 3d-cam, involving two-staged process. 1. translation and cultural adaptation of 3d-cam into the malay language. 2. testing for validity and reliability of the translated 3d-cam tool to detect postoperative delirium.

1. translation and cultural adaptation the research panel, who consisted of experts in the clinical field of anesthesia, did the meticulous process of translation and cultural adaptation of 3d-cam. this process included independent translation by the research panel, reconciliation of two independent translated 3d-cam, ethics approval prior to pilot study on 20 relevant subjects, back translation into english and finalizing the malay version of 3d-cam for the next phase of testing. 2. testing for validity and reliability of the translated 3d-cam tool patients were recruited pre-operatively after reading the patient's information sheet and signing the informed consent. post-operatively, two trained assessors separately administered the malay 3d-cam on the recruited patients. one of the trained assessors administered the original 3d-cam on the same patients at a different time. standard reference of diagnosing delirium was made by a psychiatrist using the dsm v criteria, after interviewing the patients. 1. for validity, the diagnosis of delirium made using the malay 3d-cam tool was tested against the standard reference for diagnosing delirium according to the dsm v criteria made by a psychiatrist 2. for inter-rater reliability, the diagnosis of delirium made by two trained assessors using the malay 3d-cam tool were statistically compared. 3. for parallel reliability, the diagnosis of delirium made using the malay 3d-cam was compared to the original english version of 3d-cam.

Eligibility criteria:
inclusion criteria: * age 65 years old and above * patients undergoing non-cardiac surgery exclusion criteria: * patients undergoing cardiac surgery * unable to communicate in the malay language * patients who were in the intensive care unit peri-operatively * patients whose surgery was cancelled * patients who were deaf and dumb * patients who had been diagnosed as delirious or has psychosis history before assessment * glasgow coma scale of \< 12 / 15 * patients who remained comatose throughout the investigation
a safety extension study in patients with erythropoietic protoporphyria (epp)

Conditions: Erythropoietic Protoporphyria

Summary: the main objectives of the study were to evaluate the safety and tolerability of afamelanotide by measuring treatment emergent adverse events (aes) and to determine whether afamelanotide can improve the quality of life of epp patients.


Eligibility criteria:
inclusion criteria: * male or female subjects with a positive diagnosis of epp who successfully completed the cuv017 or cuv029 studies; * aged 18-75 years (inclusive); * provide written informed patient consent prior to the performance of any study-specific procedure. exclusion criteria: * any serious adverse event considered to be related to afamelanotide or the polymer contained in the implant; * any allergy to lignocaine or other local anaesthetic to be used during the administration of the study medication; * epp patients with significant hepatic involvement; * personal history of melanoma or dysplastic nevus syndrome; * current bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions; * any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations; * acute history of drug or alcohol abuse (in the last 12 months); * female who is pregnant (confirmed by positive serum β-human chorionic gonadotropin (hcg) pregnancy test prior to baseline) or lactating; * females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device); * sexually active men with partners of child-bearing potential not using barrier contraception during the trial and for a period of three months thereafter; * participation in a clinical trial for an investigational agent within 30 days prior to the screening visit; * prior and concomitant therapy with medications which may interfere with the objectives of the study.
the role of inhalations of tranexamic acid in patients with hemoptysis

Conditions: Hemoptisis

Summary: hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that varies from blood-streaking of sputum to coughing up large amounts of pure blood. massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period. the most common site of bleeding is the tracheobronchial tree, which can be affected by inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). the bronchial arteries, which originate either from aorta or from intercostal arteries, and are part of the high-pressure systemic circulation, are the source of bleeding in bronchitis or bronchiectasis or endo bronchial tumors.


Eligibility criteria:
inclusion criteria: * age \> 18 * hemodynamicaly stable * hemoptysis of varying etiologies * coumadin treatment will be switched to clexane or heparine exclusion criteria: * age \< 18 * hemodinamicaly unstable * massive hemoptysis ( \> 200 ml / day) * renal failure: creatinine \> 3, renal replacement treatment * hepatic failure: bilirubin \> 2 mg/dl, ast \> 3 of upper normal limit level * coagulation disorders, inr\> 2. * hypesensitivity to tranexamic acid * pregnant woman

Keywords: hemoptisis bleeding tranexamic acid
hydroxychloroquine treatment for severe covid-19 pulmonary infection (hydra trial)

Conditions: COVID-19; Severe Acute Respiratory Syndrome

Summary: double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for covid-19 severe respiratory disease. the investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory covid-19 disease.

since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects against covid-19 in vitro. the investigators aim to study the security and efficacy of this drug in trough a double blinded randomized clinical trial. recruited patients with severe respiratory disease from covid-19 will be randomized to an intervention group (400mg per day dose of hydroxychloroquine) and placebo. the investigators' main outcome will be all cause hospital mortality. the investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory covid-19 disease. results will be compared in an intention to treat analysis. all clinical, analysis and data team members will be blinded to treatment assignment.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. negative pregnancy test in women 3. covid-19 confirmed by rtpcr in any respiratory sample. 4. severe covid-19 disease defined as any from the following: 1. pulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia 2. need for mechanical ventilation (invasive or non invasive ) 3. sepsis/septic shock. exclusion criteria: 1. history of anaphylactic shock to hydroxychloroquine. 2. history of previous administration of chloroquine or hydroxychloroquine (within 1 month) 3. decision of attending physician by any reason. 4. history of chronic hepatic disease (child-pugh b or c) 5. history of chronic renal disease (gfr less than 30)

Keywords: covid-19 severe acute respiratory syndrome
lamivudine and plasma markers of inflammation in retinal detachment

Conditions: Retinal Detachment; Rhegmatogenous Retinal Detachment

Summary: the goal of this clinical trial is to test whether an oral medication (lamivudine) enters the eye and reduces blood markers of inflammation in people who undergo retinal detachment surgery (pars plana vitrectomy). participants will take the study medication or placebo, and the researchers will measure blood markers of inflammation before and after surgery. the researchers will also measure the amount of medication in the blood and fluid inside the participant's eye (which is collected during surgery).

lamivudine is an anti-viral medication that has intrinsic anti-inflammatory properties that could be useful in the treatment of vitreoretinal disease. it is not known whether lamivudine enters the eye after oral administration. the purpose of this study is to measure the intra-ocular concentration of lamivudine after oral administration in participants that require pars plana vitrectomy surgery for repair of rhegmatogenous retinal detachment. participants undergoing retinal detachment surgery will receive oral lamivudine for three days prior to surgery; lamivudine will be measured intra-operatively (vitreous and aqueous humor) and pre-operatively (plasma). plasma markers of inflammation will be measured before and after surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 18 or ≤ 75 years * patients with rhegmatogenous retinal detachment that require vitrectomy surgery exclusion criteria: * previous pars plana vitrectomy in the affected eye * positive for hepatitis b surface antigen or hiv antibodies, or history of hepatitis b/hiv * pregnant or breast-feeding * liver disease or abnormal ast/alt * renal impairment (creatinine clearance \< 50) * diabetes with current use of insulin * anemia (hemoglobin \<13.2 g/dl (male) or \< 11.6 g/dl (female)) * unwilling to hold concurrent use of sorbitol or sorbitol-containing medications or products while taking study medication(including, but not limited to: blackberries, raspberries, strawberries, stone fruits, apples, avocados, sugar-free items such as chewing gum, hard candies, snack bars, frozen desserts, and chocolates, liquid and capsule/caplet analgesics, cough/cold/flu syrup, liquid and capsule/caplet pseudoephedrine, chewable antacid tablets, liquid and capsule allergy medications, motion sickness and nausea medications) * current use of trimethoprim-sulfamethoxazole * pancreatitis or history of pancreatitis * uncontrolled blood pressure (\> 160 mm hg systolic or \>100 mm hg diastolic) within the last 3 months, or current use of more than one anti-hypertensive medication * history of stroke, myocardial infarction, or congestive heart failure * current vitreous hemorrhage that obscures view of retinal details * patients with a shallow anterior chamber or in whom anterior chamber paracentesis is considered unsafe

Keywords: vitrectomy surgery
evidence-based tobacco cessation strategies in patients with cancer

Conditions: Malignant Neoplasm

Summary: this pilot clinical trial studies evidence-based tobacco cessation strategies in patients with cancer. stop-smoking plans suggested by doctors may help patients with cancer quit smoking.

primary objectives: i. to assess oncology providers' self-reported need for training on evidence-based tobacco cessation strategies and assess their level of interest in future training on evidence-based tobacco cessation strategies. ii. to test the feasibility of the implementation of evidence-based tobacco cessation strategies in community oncology clinics. iii. to test the feasibility of surveying community oncology patients after a clinic visit to assess provider behavior regarding screening and brief intervention for tobacco use. outline: patients complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting. after completion of study, patients are followed up at 1 month.

Eligibility criteria:
inclusion criteria: * all patients with cancer who saw a provider will be eligible exclusion criteria: * having a nurse or lab visit only